MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET HELICAL NANO 2 MM X 6 CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035452060
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly, and performance specifications.Visual and microscopic examination of the return device found that the coil was stretched and broken and experienced friction when advancing through introducer sheath.The coil suture was damaged, and the coil delivery wire kinked/bent.Functional testing was performed, the coil could not be advanced through the introducer sheath, it could only be retracted.The reported event was confirmed during device analysis based on the damage noted to the device.Information available indicated that the device was confirmed to be in good condition prior to use.Based on the information available and device analysis, it is likely that the coil was damaged during use resulting in the reported friction.An assignable cause of procedural factors will be assigned to the analyzed main coil broken/fractured.
Event or Problem Description
Based on the investigation of the returned product, the coil (subject device) was found to be broken/fractured.There were no clinical consequences to the patient.

• Brand Name: TARGET HELICAL NANO 2 MM X 6 CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8214402
• Report Number: 3008881809-2019-00003
• Device Sequence Number: 1987292
• Product Code: HCG
• UDI-Device Identifier: 07613252600381
• UDI-Public: 07613252600381
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• PMA/510(K) Number: K153658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/24/2021
• Device Catalogue Number: M0035452060
• Device Lot Number: 20478989
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2018
• Initial Report FDA Received Date: 01/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1